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Transcript

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0:00

My name is Christian Lenk from
the Institute for the History,Theory & Ethics of Medicine
at Ulm University in Germany.And I'm also the Chair
of the Research Ethics Committeeat my university.And today I will talk to you
about the theme,The Ethical and Legal Frameworkfor International
Tissue Transfer.

0:22

On table of contents,
you see thatI will first give you
a short introductioninto the theme,and then I will go into
some more theoretical issuesfor the introduction,
namely the no-property rule,then the bundle theory
of property,and the problem
of commodificationof body material.And then I will gomore to practical
issues of transferof human tissue for research,and then the last points
come to some conclusionsfor the practice of
research that are surelyalso interesting for you.

1:01

I will then come to
my introduction and first,it is important to describe
the area of relevancefor my talk and
the handling of tissuefor research has to be
distinguished from other fields.For example,
tissue and body materialfrom transplantation purposes
because there you will findother ethical
and legal regulations.Many of the notions
which are used in ethics and lawdo also have a meaning
in common language,like for example,
the notion of donation,or also of commercialization.In the case of donation,
when you make a donation,in practice,
normally you will seethat this is implicitly
or explicitly boundto a specific use
and this is alsothe case in the area
of tissue research.Tissue or body material
is given by the donorfor a noncommercial use
normally in medical researchand on the other side,it is expected that it is
used for specifiedand described aims,
for example,non-commercial research
at the university hospital.So you see, on the one hand,the term of donation
is also used in common language,we can say,
and on the other hand,it is in a specified way
used in medical practiceand in research.And then you have to see,
okay,what issues
are there important for meif I talk of tissue donation?And so we can say obviously
also in medical research,we have then
the donation as a giftwith a specified use
and the researcherhas then the right to use
the tissue in a specified way.You can also say about the time
that we have different ethicaland legal qualities
of human tissue.For example, first,
it is donated from the patient,the tissue,
but then it might changeits character or its quality.For example, if it is used
as a medicinal product,like, for example,
a blood donation.We can also say
that sometimes there aredifferent ethical
and legal qualitiesof human tissue.For example, directly
at the donation then tissueor body material
comes from the patientand then it is used
in the medical systemfor other purposes.Think of a blood donation,
for example,if you do something
with this body materialand later on, you can use it,
for example,as a medicinal product.Then it is very important to see
that in different countries,there are also different ethical
and legal regulations.For example,
in the European areaor in the US area,and I only want to
give you one examplefor such a regulation
and this is the last point,the recommendation REC
from 2006 number 4of the Council of Europe,
from the Committee of Ministerson research
on biological materialsof human origin
and for medical research,such recommendations
and guidelinesare very important
to see for a larger area,like here for the
European countries, okay.What are common rules
for the treatmentand for dealing
with human tissueand body material,and this makes it quite easier,
for example,in the international context,to have contact with
colleagues in other countriesand to use also body material
from other countries.And if you take this
recommendation,for example, then you
have an overview aboutthe most important points there,namely the information of patients,how you should use
body material for researchand also what limitations
there are, for example,in respect to possible
commercializationof body material.The last point
is very important.